Kornimate/medical-research-clean huggingface dataset:
oxycodone and pregabalin for the treatment of oncological neuropathic pain

Conditions: Cancer; Pain

Summary: the aim of the study is to assess tolerability and activity of oxycodone and pregabalin in combination for the treatment of oncological neuropathic pain with two different strategies.

neuropathic pain is frequently diagnosed as a complication of cancer pain. while opioids are the mainstay of cancer pain management,their efficacy in neuropathic pain seems to be less then optimal,and adjuvant drugs, mainly anticonvulsants and antidepressants,are often combined with opioids in the analgesic regimen of patients with neuropathic cancer pain. this approach is suggested by well-established guidelines, but the analgesic benefit and the safety of pregabalin and oxycodone in combination is not yet documented. the aim of this study is to assess the activity and tolerability of the addition of pregabalin to oxycodone in the treatment of patients with neuropathic pain due to neoplasm.

Eligibility criteria:
inclusion criteria: * instrumental and clinical diagnosis of every malignant neoplasm * presence of pain with a neuropathic component in the opinion of the physician * presence of pain \>=4(nrs) * ps ecog \<3 * written informed consent exclusion criteria: * serum creatinine \>2mg/ml or creatinine clearance \<40 ml/min * mild or severe hepatic insufficiency * iatrogenic neuropathy caused by chemotherapeutic agents * previous allergic reactions to oxycodone and pregabalin * pregnancy or breastfeeding

Keywords: neuropathic pain oxycodone pregabalin patients with cancer and presenting a neuropathic pain
development of mental health treatment for obstetric fistula patients in tanzania

Conditions: Other Obstetric Trauma OS

Summary: the purpose of this study is to determine whether a mental health intervention for obstetric fistula patients in tanzania improves primary outcomes (depression, ptsd and somatic symptoms) and secondary outcomes (coping, perceived stigma, social support, social participation, efficacy to engage with providers, adherence to clinical recommendations and social reintegration).

obstetric fistula is a hole between the bladder or rectum and the vagina, which develops when obstructed labor is not relieved by cesarean section and results in uncontrollable leaking of urine and/or feces. the only cure for obstetric fistula is surgical repair. multiple studies have documented the social and psychological impact of obstetric fistula, which includes social isolation, stigma, depression, and mental health dysfunction. the surgical repair setting can be a window of opportunity to address the accumulated mental health distress of living with a fistula. however, to date no intervention studies have evaluated empirically-supported therapies to assist in psychological healing among fistula patients. the proposed study aims to fill this gap by developing and pilot-testing a theoretically informed mental health intervention for women receiving surgical repair for obstetric fistula at kcmc hospital in moshi, tanzania. the study has three specific aims: 1) to develop the nurse-delivered mental health intervention, built on theories of coping and cognitive behavioral therapy, 2) to assess feasibility and acceptability of implementing the intervention in the kcmc fistula ward, considering: intervention fidelity, patient satisfaction, provider feedback and cost of delivery, 3) to assess effectiveness of the intervention by comparing immediate and short term outcomes in 30 women who receive the experimental intervention with 30 women receiving the standard of care counseling, examining differences in primary outcomes (depression, ptsd and somatic symptoms) and secondary outcomes (coping, perceived stigma, social support, social participation, efficacy to engage with providers, adherence to clinical recommendations and social reintegration). the proposed research directly responds to the needs specified by nih because it expands the "evidence base for improving social outcomes" of women with obstetric fistula and develops a "sustainable intervention" that complements existing local care (pa-11-143). at the completion of this study, it is our expectation that we will have a structured intervention curriculum and supportive preliminary data to inform an r01 application to conduct a multi-site evaluation of the intervention, which, if effective, can be disseminated to fistula repair clinics internationally.

Eligibility criteria:
inclusion criteria: * patients at the kilimanjaro christian medical center obstetrics-gynecology department, receiving surgical repair for a fistula resulting from childbirth exclusion criteria: * impaired mental status

Keywords: obstetric fistula mental health tanzania
intraoral device vs facial mask for class iii treatment

Conditions: Class III Malocclusion; Dentofacial Anomalies, Including Malocclusion

Summary: the aim of this randomized controlled trail is to compare the efficacy of an intraoral device (the carriere® motion 3d™ class iii appliance) with the facial mask for the early treatemnt of class iii malocclusion. this is a monocentric, parallel, controlled trial with blinded examiner.


Eligibility criteria:
inclusion criteria: * age between 5 and 8 years * prepubertal patients (cervical vertebral stage 1 or 2) * deciduous, early mixed, and intermediate mixed dentition (the lower deciduous canine should show at least 2/3 of the roots unresorbed) * presence of class iii skeletal imbalance (wits appraisal equal to or smaller than * 1 mm) exclusion criteria: * early root resorption of the lower deciduous canines * periodontal disease * neurologic diseases * nickel allergy * patients with cleft lip and palate or craniofacial syndromes * patients irradiated in the head and neck area * patients who have undergone chemiotherapy or immunosuppresive therapy in the previous 5 years * patients unable to be followed for at least 1 year
pain comparison whit visual analog scale (eva) between four analgesic methods during trans rectal prostatic biopsy

Conditions: Cancer of Prostate

Summary: define the best analgesic method between peri prostatic blockage, analgesic suppository, oral analgesic and topic anesthetic gel, during trans rectal prostate biopsy

comparison between four analgesic methods during trans rectal prostatic biopsy. objective: to define the best analgesic method between the peri-prostatic block, the analgesic suppository, the oral analgesic, the final anesthetic gel, during the trans rectal prostate biopsy determined at the end of the procedure with a visual analogue scale for pain (vas pain) in a interview 15 to 30 minutes at the end of the procedure. methods: experimental, retrospective, longitudinal, comparative, during may to july 2017, 350 trans rectal prostate biopsies were performed, all cases were randomly assigned to one of the four study groups. the data analysis will be performed by calculating measures of central tendency and dispersion for quantitative variables and anova test, for qualitative variables chi square to determine statistical differences between the three moments of pain in the parameters of introduction of the ultrasound transducer, sampling of prostate of the minimum 12 biopsies and discomfort in general of the procedure

Eligibility criteria:
inclusion criteria: * male patients older than 18 years with indication for trans rectal prostate biopsy exclusion criteria: * bad intestinal preparation. * painful anorectal pathologies. * clotting disorders without previous assessment by hematology. * acute prostatitis

Keywords: cancer of prostate analgesic method
a randomized trial of avastin + gemcitabine + 5-fluorouracil (5fu)/folinic acid versus avastin + oxaliplatin + 5fu/folinic acid in metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: the purpose of the study is to describe the tumor response rates for the two regimens being studied, and to determine how long patients live after receiving the treatment, how long patients are without return of their disease after they receive treatment, and how long the response they get from the treatment lasts. the amount and type of side effects/toxicities of each regimen will also be evaluated. the regimen including oxaliplatin + 5fu/folinic acid is a current standard of care.


Eligibility criteria:
inclusion criteria: * patients must have a histological or cytological diagnosis of the colon or rectum with stage iii unresectable or stage iv disease. * urinalysis or urine dipstick for proteinuria of less than 1+ (i.e. either 0 or trace). if urine dipstick is greater than 1+, the 24 hour urine protein must demonstrate less than 500 mg of protein in 24 hours to allow participation. * no prior chemotherapy, immunotherapy, or hormonal treatment for metastatic disease is acceptable. however, one prior neo-adjuvant or adjuvant treatment is acceptable, including capecitabine, camptothecin-11 (cpt-11), 5 fluorouracil/leucovorin (5fu/lv) or radiation containing regimens, (but no oxaliplatin), and only if progression \> 6 months since last adjuvant treatment. * prior radiation therapy, including radiation to the whole pelvis, is allowed (cristy and eckerman 1987) and patients must have recovered from the acute toxic effects of the treatment prior to study enrollment. prior palliative radiation therapy given to a non-measurable diagnostic site is acceptable if given \> 4 weeks prior to treatment or if other non-irradiated measurable disease is present. * no known central nervous system (cns) metastasis. exclusion criteria: * histology other than adenocarcinoma * tumors that demonstrate free perforation as manifested by free air or free fluid in the abdomen. patients with walled-off perforation are eligible. * gastroduodenal ulcer determined as active by endoscopy. * invasive procedures defined as follows; major surgical procedures, open biopsy, or significant traumatic injury within 28 days prior to randomization, anticipation of need for major surgical procedure during the course of study, core biopsy or other minor procedure within 7 days prior to registration. * following cardiac condition; new york heart association (nyha) class iii or iv, myocardial infarction (mi) within 6 months, unstable angina within 6 months and current symptomatic arrhythmia.
management and coaching in atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to evaluate the effect of a cognitive behavior therapy distress management program targeting wellbeing in patients with atrial fibrillation and their relatives.

a randomized controlled design with pre- and 12 month posttest including persons living with atrial fibrillation and their relatives. the distress management program (cognitive behavioral therapy) delivered in groups by a specialistnurse, a pedagogue and a cardiologist all trained in the distress management program. the program delivered to participants into three group- sessions extensive two hours each during a five weeks period 2011-2013. eligible participants were all consecutive identified when discharge after hospital care due to atrial fibrillation. the random process were managed by an open-label computer as block - randomization. participants were enrolled and randomized during 2011-2013 into two arms; either to an experiment group to the distress management program or the control group. the trial, run alongside the standard care all of the participants received at a cardiology unit in a county hospital. the standard care was required to following actual guidelines.

Eligibility criteria:
inclusion criteria: * patients diagnosed with atrial fibrillation. * relative to patient with atrial fibrillation. * to be over 18 years old . exclusion criteria: * unwillingness to participate in the study. * other complicating illness'. * language difficulties that prevent answering surveys. * participation in another study. * accommodation outside the hospital's catchment area.

Keywords: sense of coherence
a research study looking at the safety of single doses of zp9830 and how it works in the body of healthy participants

Conditions: Autoimmune Diseases

Summary: the primary object in this research study is to investigate the safety and tolerability of zp9830 in healthy study participants, and in addition, the study will investigate how zp9830 works in the body (pharmacokinetics, pk and pharmacodynamics, pd) compared to placebo.

part a: participants will receive 1 dose either zp9830 or placebo as an injection under the skin (subcutaneous, s.c), and safety and pk will be assessed. part b: participants will receive 1 dose either zp9830 or placebo as an injection under the skin (subcutaneous, s.c.) and safety, pk and pd will be assessed. part c: participants will receive 1 dose either zp9830 or placebo as intravenous (i.v.) dose, and safety and pk will be assessed.

Eligibility criteria:
inclusion criteria: healthy male subject. 18-45 years of age (inclusive). body weight ≥50 kg. part b only: fitzpatrick skin type i-iii (caucasian). c-reactive protein ≤10 mg/l. further inclusion criteria apply. exclusion criteria: evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of it might interfere with, the conduct or the interpretation of the results of the trial, or that would pose an unacceptable risk to the subject in the opinion of the investigator \[following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature) and 12-lead ecg\]. any disease associated with immune system impairment, including immune mediated diseases and transplantation patients. any confirmed significant allergic reactions (urticaria or anaphylaxis) to insect bites. history of neurological disorders including neuropathy, as judged by the investigator. any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug or food (in particular any level of severity of allergy to shellfish), or multiple drug allergies (non-active hay fever is acceptable). further exclusion criteria apply.
double-blind, placebo-controlled, randomized study of the effectiveness of escitalopram on emotional distress of head and neck cancer patients during cancer treatment

Conditions: Carcinomas

Summary: evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months in patients with head and neck squamous cell carcinomas (oral cavity, larynx, oropharynx and hypopharynx) and with an hads total score \> 11


Eligibility criteria:
inclusion criteria: 1. head and neck squamous cell carcinomas, stage i to ivb 2. first-line curative cancer therapy : surgery and/or brachytherapy and/or chemotherapy 3. hads- t \>11 4. aged 18 to 75 yo, written consent required 5. oms\>2 exclusion criteria: 1. palliative care 2. previous head and neck cancer 3. bipolar disorder or schizophrenia 4. severe major depressive disorder (dsm-iv tr) 5. expressed suicidal ideation 6. severe untreated organic disorder, especially acute infectious disorder 7. asat/alat \> 3n 8. clearance of creatinin \< 30 ml/mn 9. hyponatremia 10. antecedent of delirium tremens or acute alcohol withdrawal disorder 11. antecedent of upper gastro-intestinal bleeding 12. antecedent of toxicity or inefficacy of a previous treatment with escitalopram 13. unauthorized treatments :- antidepressant or antiepileptic (clonazepam authorized)- hypnotic except zolpidem - anxiolytic except clonazepam, clorazepate or diazepam- bupropion or varenicline 14. pregnancy or lactation

Keywords: patients with head and neck squamous cell carcinomas head and neck squamous cell carcinomas
darifenacin x parasacral transcutaneous electric nerve stimulation for oab in patients infected with human t-lymphotropic virus 1

Conditions: HTLV-1; Overactive Bladder Syndrome

Summary: in this study the investigators compare the parasacral transcutaneous electric nerve stimulation (ptens) treatment with darifenacin to improve oab symptoms in patients infected with htlv-1.

subjects presenting oab according to ics, associated with the htlv-1 infection were invited by the investigators to participate in the study according inclusion criteria . participants who accepted were randomly allocated to two groups (g1 and g2) by the free randomization website. group 1 was treated with darifenacin, and group 2 with the ptens protocol. drug treatment protocol: the anticholinergic fenazic (adium) was used in a single dose of 15mg/day for 2 months. ptens protocol: the treatment consisted of ptens with the neurodyn portable tens fes(21) neuromuscular stimulation device in an outpatient clinic. two self-adhesive electrodes (5x9cm) were used, positioned one in each gluteal region, below the iliac spine to apply low-frequency biphasic current with 10 hz. pulse duration of 0.5 milliseconds was applied for 40 minutes with continuous stimulation, 3 times a week, for 20 sessions.

Eligibility criteria:
inclusion criteria: * htlv-1 infection * overactive bladder symptom * 18 years of age or older exclusion criteria: * htlv-1 infected subjects with ham * stroke * parkinson * hiv infection * prostatic hyperplasia * pacemaker use * genitourinary tract infection * glaucoma

Keywords: electrical stimulation overactive bladder hltv-1 darifenacin
ipf mhealth exercise study

Conditions: Idiopathic Pulmonary Fibrosis

Summary: patients with idiopathic pulmonary fibrosis (ipf) who are stable on antifibrotic therapy at least 3 months will be randomized to complete a 12-week home exercise intervention using an mhealth platform, plus a pre- and post-intervention monitoring period (4 weeks each) and in-person study assessments.

contemporary walk test endpoints in ipf trials may under-represent patient functional gains with antifibrotic therapy, which may be more effectively captured with long-term activity monitoring. traditional pulmonary rehabilitation centers create a barrier to patient exercise accessibility and compliance, which is eliminated in a mobile health (mhealth) exercise training approach. in this study, 30 patients with ipf will be randomized into one of two arms. the exercise arm will receive a 12-week home exercise intervention using an mhealth platform plus pre- and post-intervention monitoring (4 weeks each). the non-exercise arm will be monitored for the same study duration. the primary end point is change from baseline in daily physical activity as a number of weekly exercise minutes qualifying as moderate to vigorous physical activity (mvpa), mets\*minutes of exercise per week, and sedentary time minutes. assessments will be performed primarily via in-person study visits at week 4 and week 16, as well as via daily recordings from mhealth monitoring devices.

Eligibility criteria:
inclusion criteria: * age 40-80 yrs at randomization * diagnosis of idiopathic pulmonary fibrosis (ipf), consistent with the ats 2018 guidelines * percent forced vital capacity (%fvc) ≥50% * percent carbon monoxide diffusing capacity (%dlco) ≥30% * willing and able to participate in an exercise regimen * ambulatory without the use of an assistive device * stable on antifibrotic therapy (pirfenidone or nintedanib) at least 3 months * no changes in other medication for at least 4 wks before enrollment * must be able to read, write, and verbally communicate in english exclusion criteria: * forced expiratory volume in one second (fev1)/fvc ratio \<0.7 after administration of bronchodilator at screening * expected to receive a lung transplant within 1 year from randomization or, for patients at sites in the united states, on a lung transplant waiting list at randomization * known explanation for interstitial lung disease * history of asthma or chronic obstructive pulmonary disease * active infection * ongoing ipf treatments including investigational therapy, immunosuppresents (other than prednisone 20 mg daily and below) and cytokine modulating agents * participation in a supervised exercise program including pulmonary rehab within the previous 12 months * history of unstable or deteriorating cardiac or pulmonary disease (other than ipf) within the previous 6 months * major orthopedic, psychiatric, neurological, or other conditions that would impair performance of the study exercise outcomes * require \>5lpm supplemental o2 at rest * currently pregnant
comparison of laparoscopic nissen versus thal fundoplication in children

Conditions: Gastroesophageal Reflux Disease

Summary: laparoscopic fundoplication is increasingly performed in paediatric surgery. many types of fundoplication are performed, each has advantages and disadvantages. the nissen operation is the most frequently performed procedure in the u.k., however it can be associated with post-operative dysphagia. the relative benefits between nissen and other fundoplication techniques in children are still uncertain. the aim of our study was to compare the long-term outcomes following laparoscopic nissen fundoplication with laparoscopic thal fundoplication in children.


Eligibility criteria:
inclusion criteria: * gastro-oesophageal reflux unresponsive to medical treatment, or those who had serious complications (e.g. apnoea, aspiration pneumonia, oesophagitis) exclusion criteria: * patients who had previous anti-reflux surgery, previous open abdominal surgery, if parents declined to participate into study

Keywords: laparoscopy fundoplication nissen thal children operative treatment of gastro-oesophageal reflux disease in children
everolimus (rad001) and carboplatin in pretreated metastatic breast cancer

Conditions: Breast Cancer

Summary: this is an open-label, mono-center phase i/ii study designed to determine the maximum tolerated dose (mtd) and dose-limiting toxicities (dlt) of rad001 in combination with carboplatin in taxane- and anthracycline-pretreated patients with progressive metastatic breast cancer. additionally, the study is designed to characterize the safety, the tolerability and efficacy of this study.

during the phase i part the study will include at least 3 patients at each dose-level until mtd is reached. each cohort will consist of newly enrolled patients. intra-patient dose escalation is not permitted. once mtd is reached a total of 6 patients will be treated at mtd (phase i). for the phase ii the minimax two-stage design will be applied. after testing the drug on 16 patients in the first stage of phase ii, the trial will be terminated if 1 or fewer respond (sd, pr, cr). if the trial goes on to the second stage, a total of 34 patients will be studied during the phase ii part.

Eligibility criteria:
inclusion criteria: * adult female patients * at least two prior chemotherapies due to metastatic or inoperable breast cancer * karnofsky performance status of at least 60% * pretreatment with at least one taxane and one anthracycline exclusion criteria: * previous treatment with mtor-inhibitors, carboplatin, cisplatin or oxaliplatin * inadequate organ function including bone marrow function * bleeding tumours * known uncontrolled metastases in cns or carcinomatous meningosis * patients who have been treated during the last five days with inhibitors or inducers of cyp3a * serious pulmonary, neurological, endocrinological or other disorders interfering with this study medication, especially patients with known lung fibrosis, emphysema or severe copd